A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to gain information on whether apixaban, when administered to patients with advanced or metastatic cancer will be well-tolerated and acceptable as anticoagulant therapy. These patients are at increased risk for venous thromboembolic events (VTE). Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment. |
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Condition | Thrombosis Cancer Pulmonary Embolism |
Intervention | Drug: Apixaban Drug: Placebo |
Phase | Phase 2 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00320255 |
First Received | April 28, 2006 |
Last Updated | February 28, 2012 |
Last verified | February 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | April 28, 2006 |
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Last Updated Date | February 28, 2012 |
Start Date | June 2006 |
Estimated Primary Completion Date | January 2009 |
Current Primary Outcome Measures | The occurrence of either a major bleeding (fatal or non-fatal) event or a clinically relevant non-major bleeding event [Time Frame: during the treatment period] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Symptoms compatible with venous thromboembolism [Time Frame: during the treatment and 30 day follow-up periods] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer |
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Official Title | A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study |
Brief Summary | The purpose of this study is to gain information on whether apixaban, when administered to patients with advanced or metastatic cancer will be well-tolerated and acceptable as anticoagulant therapy. These patients are at increased risk for venous thromboembolic events (VTE). Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
Condition |
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Intervention | Drug: Apixaban Tablets, Oral, 5 mg QD, once daily for 12 weeks Other Names: BMS-562247Drug: Placebo Tablets, Oral, 0 mg, once daily for 12 weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 129 |
Estimated Completion Date | January 2009 |
Estimated Primary Completion Date | January 2009 |
Eligibility Criteria | Inclusion Criteria: - Advanced or metastatic cancer - Chemotherapy for ≥90 days - Enter study within 6 wks start of chemo Exclusion Criteria: - Women who are pregnant, breastfeeding - Venous Thromboembolic Events (VTE) history - Active/high risk of bleeding - Metastatic brain cancer - Expected survival < 6 months - Bone marrow transplant candidate - Low platelet count - ALT >3xULN, bilirubin > 2xULN, Clcr <30 mL/min - Receiving Plavix® Aggrenox™ - Receiving bevacizumab (Avastin™ ) for off-label/investigational indications - Receiving Nexavar® or Sutent® (within 3 months) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00320255 |
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Other Study ID Numbers | CV185-027 |
Has Data Monitoring Committee | Yes |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Ontario Clinical Oncology Group (OCOG) |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | February 2012 |
Locations[ + expand ][ + ]
Arizona Cancer Center | Tucson, Arizona, United States, 85724 |
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Univ. Of Southern Calif. /Norris Comprehensive Cancer Center | Los Angeles, California, United States, 90033 |
Dana-Farber Cancer Inst | Boston, Massachusetts, United States, 02115 |
Nevada Cancer Institute | Las Vegas, Nevada, United States, 89135 |
Mount Sinai School Of Medicine | New York, New York, United States, 10029 |
Memorial Sloan-Kettering Cancer Center | New York, New York, United States, 10021 |
University Of Rochester | Rochester, New York, United States, 14642 |
University Of Texas Md Anderson Cancer Ctr | Houston, Texas, United States, 77030 |
Local Institution | Hamilton, Ontario, Canada, L8V 2C5 |
Local Institution | London, Ontario, Canada, N6A 4L6 |
Local Institution | Toronto, Ontario, Canada, M5G 2M9 |
Local Institution | Toronto, Ontario, Canada, M4N 3M5 |
Local Institution | Montreal, Quebec, Canada, H3G 1A4 |
Local Institution | Montreal, Quebec, Canada, H1T 2M4 |